We conducted a feasibility study to evaluate the feasibility of recruiting patients to examine the effect of near vision glasses in young infants at risk of cerebral visual impairment.

A three-arm, parallel-group, open-label randomised feasibility trial.

Tertiary neonatal intensive care in London, UK.

We included babies born before 29 weeks of gestation or at full term with hypoxic ischaemic encephalopathy. Babies who needed ongoing inpatient care, with established eye anomalies or with very high refractive errors at baseline (±8.00D) were not included. Infants with retinopathy of prematurity were not excluded.

At 8 weeks corrected age, we allocated 18 infants to wear glasses (+3.00D over full cycloplegic refraction) immediately (intervention 1), 18 to wear the same glasses at 16 weeks (intervention 2) and 19 infants were allocated to standard treatment (no glasses).

Recruitment and retention of study participants (primary), compliance wearing glasses, preferential-looking visual acuity (with glasses) and visual function as determined using A Test Battery of Child Development for Examining Functional Vision at 3-month and 6-month age post-term.

Of 70 eligible families, 55 consented and 34 attended baseline assessments, and 28 completed the study. Non-attendance was due mainly to prolonged inpatient stay, infant health and scheduling conflicts. Glasses were worn for similar periods in each group (Intervention 1: median 2 hours/day (95% CI 1 hour to 4 hours); Intervention 2: median 2 hours/day (95% CI 1.5 hours to 3 hours)). Visual acuity improved from baseline to 6 months. Mean (SE) LogMAR (Minimum Angle of Resolution) improvements were standard care: 0.47 (0.45); intervention 1: 0.66 (0.44); intervention 2: 0.37 (0.36). Among the 29 very preterm infants, there were similar findings: standard care: 0.35 (0.35); Intervention 1: 0.67 (0.47); Intervention 2: 0.34 (0.40). As a functional measure, object permanence was present at the following rates by randomised arm: standard care: 29%; whereas intervention 1: 56%; and intervention 2: 44% (OR intervention 1 vs standard care: 3.13 (95% CI 0.38 to 25.57), ie, not statistically significant).

We demonstrate feasibility for a definitive RCT (randomized controlled trial) with good recruitment and retention and observed potential benefits for vision and development following the dispensing of glasses at 8 weeks post-term age compared with untreated controls. We identified methodological modifications to further improve recruitment processes for a future larger study.

ISRCTN14646770; NCT05048550.

Neonatal death and later disability remain common sequelae of hypoxic-ischaemic encephalopathy (HIE) despite the now standard use of therapeutic hypothermia (HT). New therapeutic approaches to brain protection are required. Melatonin is an indolamine hormone with free-radical scavenging, antiapoptotic, anti-inflammatory and gene regulatory neuroprotective properties, which has extensive preclinical evidence of safety and efficacy. Pharmacokinetic (PK) data suggest it is necessary to reach melatonin levels of 15–30 mg/L within 6–8 hours of hypoxia-ischaemia for brain protection. We developed a novel Good Manufacturing Practice (GMP) grade melatonin in ethanol 50 mg/mL solution for intravenous use. In preclinical studies, ethanol is an adjuvant excipient with additional neuroprotective benefit; optimised dosing protocols can achieve therapeutic melatonin levels while limiting blood alcohol concentrations (BACs).

The Acute High Dose Melatonin for Encephalopathy of the Newborn (ACUMEN) Study is a first-in-human, international, multicentre, phase 1 safety study of intravenous melatonin in babies with moderate/severe HIE receiving HT. Sixty babies will be studied over two phases: a dose escalation study including four dose levels to establish the recommended phase 2 dose (RP2D), followed by a 6-month cohort expansion study of RP2D to further characterise PKs and affirm safety. Participants will receive a 2-hour intravenous infusion of melatonin within 6 hours of birth, followed by five maintenance doses every 12 hours to cover the period of HT. Plasma melatonin and BACs will be monitored. The RP2D will be based on the attainment of therapeutic melatonin levels while limiting BACs and the frequency of dose-limiting events (DLEs). A Bayesian Escalation with Overdose Control approach will be used to estimate the risk of DLE per dose level, with a target level of

Approval has been given by the London Central National Health Service Health Research Authority Ethics Committee (25/LO/0170) and UK Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency. Separate approvals have been sought in Ireland and Australia. Dissemination will be via peer-reviewed journals, conference presentations, public registries and plain language summaries for parent/legal guardian(s), in accordance with national requirements.

ISRCTN61218504. EU CT: 2025-520538-49-00.

Publication based on the UK protocol V.3.0, 08 May 2025

Fathers are intricately bound to the experience of adolescent mothers and their children. Yet, fathers of children born to adolescent mothers, particularly within the context of HIV, remain neglected in the literature. These exploratory analyses provide insight into the characteristics of fathers of children born to adolescent mothers affected by HIV in South Africa.

Eastern Cape Province, South Africa.

Cross-sectional data from a prospective cohort study.

Young mothers (10–24 years of age) and their children (0–68 months). All mothers completed detailed study questionnaires, including standardised and study-specific measures, relating to their self, their children and the fathers of their children. Summary statistics are presented based on maternal self-report of father characteristics. ² tests and t-tests (Fisher’s exact/Kruskal-Wallis tests, where appropriate) were additionally used to explore sample characteristics (including father characteristics, maternal experience and child characteristics) according to paternal age and father involvement in childcare (defined by responses to four maternal self-report questions). Father characteristics were also explored according to maternal HIV status and maternal mental health status.

40% of fathers were adolescents (10–19 years) at the birth of their children. Overall, father involvement was low (19.5%). Compared with noninvolved fathers, involved fathers were more likely to be older when their child was born (21 years vs 20 years, t=4.30, p=0.04), to be in a relationship with the mothers of their children (74.8% vs 47.2%, ²=40.8, p≤0.0001), to reside with their children and their mothers (14.7% vs 3.7%, ²=49.3, p≤0.0001) and to attend the first antenatal appointment (4.3% vs 1.5%, ²=5.21, p=0.02). A quarter (25.4%; 227/894) of the adolescent mothers in the sample were living with HIV. The prevalence of maternal HIV was found to be higher among adolescent mothers of children born to older fathers compared with adolescent fathers (31.7% vs 15.9%, ²=28.3, p≤0.001). Likewise, depressive symptoms were more prevalent among adolescent mothers of children born to older fathers compared with adolescent fathers (9.9% vs 5.3%, ²=6.08, p=0.01). Adolescent mothers reporting poor mental health were less likely to be in a relationship with the fathers of their children (41.8% vs 54.1%, ²=7.32, p=0.03) and more likely to experience domestic violence perpetrated by the fathers of their children (8.2% vs 3.3%, ²=6.07, p=0.01) and to engage in arguments about finances with the fathers of their children (30.0% vs 17.0%, ²=10.8, p=0.001). While some differences in individual subscales were identified, overall composite scores of child cognitive development did not differ according to father age or father involvement.

Analyses provide the first preliminary description of the fathers of children born to adolescent mothers affected by HIV in South Africa. Fathers are inherently tied to the experiences of adolescent mothers and their children. Father involvement with their children was low. Further research is required to explore the potential barriers to father involvement and pathways to overcome these. Efforts to bolster father engagement, such as the inclusion of fathers within maternal and child service provision, may have benefits for fathers, adolescent mothers and their children. There was a high prevalence of adolescent fatherhood in the study. Adolescent fathers may have specific needs requiring tailored intervention for adolescent parent families. The need for the inclusion of fathers within policy, programming and research remains.